The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
379
SKK
Plantation, Florida, United States
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Change From Baseline in WOMAC VAS Stiffness Subscore
Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Change From Baseline in WOMAC VAS Physical Function Subscore
Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Change From Baseline in WOMAC VAS Total Score
Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response
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Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).
Time frame: Weeks 6 to 13
Change From Baseline in Short Form - 36 (SF-36)
Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.
Time frame: Baseline and Week 13
Change From Baseline in Subject Global Evaluations
Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Change From Baseline in Physician Global Evaluations
Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Time frame: Baseline and Week 13
Acetaminophen Consumption
Weekly mean acetaminophen consumption between weeks 9 and 13.
Time frame: Weeks 9 to 13 (5 weeks)